Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 56383 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

V. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 20, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR part 180 is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

§ 180.143 [Removed] 

■ 2. Section 180.143 is removed. 

■ 3. Section 180.301 is amended by 

revising paragraph (a) to read as follows: 

§ 180.301 Carboxin; tolerances for 

residues. 

(a) General. Tolerances are 

established for the combined residues of 

the fungicide carboxin (5,6-dihydro-2- 

methyl-1,4-oxathiin-3-carboxanilide) 

and its metabolites determined as 

aniline and expressed as parent 

compound, in or on food commodities 

as follows: 

Commodity Parts per 

million 

Barley, grain ............................. 0.2 

Barley, straw ............................. 0.2 

Bean, dry, seed ........................ 0.2 

Bean, succulent ........................ 0.2 

Canola, seed ............................ 0.03 

Cattle, fat .................................. 0.05 

Cattle, meat byproducts ........... 0.1 

Cattle, meat .............................. 0.05 

Corn, field, forage ..................... 0.2 

Corn, field, grain ....................... 0.2 

Corn, field, stover ..................... 0.2 

Corn, pop, grain ........................ 0.2 

Corn, pop, stover ...................... 0.2 

Corn, sweet, forage .................. 0.2 

Corn, sweet, kernel plus cob 

with husks removed .............. 0.2 

Corn, sweet, stover .................. 0.2 

Cotton, undelinted seed ........... 0.2 

Egg ........................................... 0.05 

Goat, fat .................................... 0.05 

Goat, meat byproducts ............. 0.1 

Goat, meat ................................ 0.05 

Hog, fat ..................................... 0.05 

Hog, meat byproducts .............. 0.1 

Hog, meat ................................. 0.05 

Horse, fat .................................. 0.05 

Horse, meat byproducts ........... 0.1 

Horse, meat .............................. 0.05 

Milk ........................................... 0.05 

Oat, forage ................................ 0.5 

Oat, grain .................................. 0.2 

Oat, straw ................................. 0.2 

Onion, bulb ............................... 0.2 

Peanut ...................................... 0.2 

Peanut, hay .............................. 0.2 

Poultry, fat ................................ 0.1 

Poultry, meat byproducts .......... 0.1 

Poultry, meat ............................ 0.1 

Rice, grain ................................ 0.2 

Rice, straw ................................ 0.2 

Safflower, seed ......................... 0.2 

Sheep, fat ................................. 0.05 

Sheep, meat byproducts .......... 0.1 

Sheep, meat ............................. 0.05 

Soybean, seed .......................... 0.2 

Wheat, forage ........................... 0.5 

Wheat, grain ............................. 0.2 

Wheat, straw ............................. 0.2 

* * * * * 

■ 4. Section 180.355 is amended by 

revising the table in paragraph (a)(1) to 

read as follows: 

§ 180.355 Bentazon; tolerances for 

residues. 

(a) General. (1) * * * 

Commodity Parts per 

million 

Bean, dry, seed ........................ 0.05 

Bean, succulent ........................ 0.5 

Corn, field, forage ..................... 3.0 

Corn, field, grain ....................... 0.05 

Corn, field, stover ..................... 3.0 

Corn, pop, grain ........................ 0.05 

Corn, sweet, kernel plus cob 

with husks removed .............. 0.05 

Commodity Parts per 

million 

Cowpea, forage ........................ 10.0 

Cowpea, hay ............................. 3.0 

Flax, seed ................................. 1.0 

Pea, dry, seed .......................... 1.0 

Pea, field, hay ........................... 8.0 

Pea, field, vines ........................ 3.0 

Pea, succulent .......................... 3.0 

Peanut ...................................... 0.05 

Peanut, hay .............................. 3.0 

Pepper, nonbell ........................ 0.05 

Peppermint, tops ...................... 1.0 

Rice, grain ................................ 0.05 

Rice, hulls ................................. 0.25 

Rice, straw ................................ 3.0 

Sorghum, forage ....................... 0.20 

Sorghum, grain ......................... 0.05 

Sorghum, grain, stover ............. 0.05 

Soybean, forage ....................... 8.0 

Soybean, hay ............................ 8.0 

Soybean, seed .......................... 0.05 

Spearmint, tops ........................ 1.0 

* * * * * 

§§ 180.1238 and 180.1239 [Removed] 

■ 5. Section 180.1238 and 180.1239 are 

removed. 

[FR Doc. 06–8255 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0016; FRL–8085–2] 

Metconazole; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of metconazole in 

or on bananas. BASF Agricultural 

Products requested this tolerance under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0016. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 


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Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket 

athttp://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, 

One Potomac Yard (South Building), 

2777 S. Crystal Drive, Arlington, VA. 

The Docket Facility is open from 8:30 

a.m. to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Mary L. Waller, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9354; e-mail address: 

waller.mary@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2005–0016 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 27, 2006. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0016, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305- 

5805. 

II. Background and Statutory Findings 

In the Federal Register of April 8, 

2005, (67 FR 18008) (FRL–7703–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E5052) by BASF 

Agricultural Products, 26 Davis Drive, 

P.O. Box 13528, Research Triangle Park, 

NC 27709–3528 agent for Kureha 

Corporation, 3–3–2 NihonbashiHamacho, Chuo-ku, Tokyo 103–8552, 

Japan. The petition requested that 40 

CFR be amended by establishing a 

tolerance for residues of the fungicide 

metconazole, 5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol, in or on 

bananas at 0.05 parts per million (ppm). 

That notice included a summary of the 

petition prepared by BASF Agricultural 

Products, the agent for the petitioner. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV,C. 

below. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 


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III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

metconazole on banana at 0.1 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing the 

tolerance follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. Specific 

information on the studies received and 

the nature of the toxic effects caused by 

metconazole as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov 

under the docket ID number EPA–HQ–

OPP–2005–0016. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which the NOAEL from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the LOAEL 

of concern are identified is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

oppfead1/trac/science/, and http:// 

www.epa.gov/pesticides/factsheets/ 

riskassess.htm. 

A summary of the toxicological 

endpoints for metconazole used for 

human risk assessment is shown in 

Table 1 of this unit: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR METCONAZOLE FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario 

Dose Used in Risk Assessment, Interspecies and 

Intraspecies and any Traditional UF 

Special FQPA SF and 

Level of Concern for Risk 

Assessment 

Study and Toxicological Effects 

Acute Dietary (Females 13-49 

years of age) 

NOAEL = 12 mg/kg/day 

UF = 100 

Acute RfD = 0.12 mg/kg/day 

Special FQPA SF = 1X 

aPAD = acute RfD/FQPA 

SF = 0.12 mg/kg/day 

Developmental toxicity - rats 

LOAEL = 30 mg/kg/day based on increases in 

skeletal variations 

Chronic Dietary (All populations) NOAEL = 4.3 mg/kg/day 

UF = 100 

Chronic RfD = 0.04 mg/kg/ 

day 

Special FQPA SF = 1X 

cPAD = chronic RfD/Special FQPA 

SF = 0.04 mg/kg/day 

Chronic oral toxicity - rats 

LOAEL = 13.1 mg/kg/day based on increased 

liver (M) weights and associated 

hepatocellular lipid vacuolation (M) and 

centrilobular hypertrophy (M). Same effects 

seen (F) at 54 mg/kg/day, plus increased 

speen weight 

Cancer (oral, dermal, inhalation) Classification: ‘‘Not Likely to be Carcinogenic to Humans’’

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. There are currently no 

tolerances established (40 CFR 180) for 

the residues of metconazole. Use of 

metconazole on soybeans has been 

authorized under Section 18 of FIFRA. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

metconazole in/on imported bananas 

and soybeans as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

In conducting the acute dietary 

exposure assessment EPA used the 

Dietary Exposure Evaluation Model 

software with the Food Commodity 

Intake Database (DEEM-FCIDTM, version 

2.03), which incorporates food 

consumption data as reported by 

respondents in the United States 

Department of Agriculture (USDA) 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the acute exposure 

assessment: Tolerance level residues 

and 100% crop treated were assumed 

for bananas and soybeans. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the software with the (DEEMFCIDTM, version 2.03), which 

incorporates food consumption data as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide CSFII, 

and accumulated exposure to the 

chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessments: 

Tolerance level residues and 100% crop 

treated were assumed for bananas and 

soybeans. 

iii. Cancer. Metconazole is classified 

as ‘‘Not Likely to be Carcinogenic to 

Humans’’ based on convincing evidence 

that carcinogenic effects are not likely 

below a defined dose range. A nongenotoxic mode of action for mouse 

liver tumors was established. An 

exposure assessment is not necessary. 

2. Dietary exposure from drinking 

water. There is no expectation that 


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residues from metconazole use on 

imported banana would occur in surface 

or ground water sources of drinking 

water. Because the Agency does not 

have comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

metconazole. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/

oppefed1/models/water/models4.htm. 

Based on the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) and Screening 

Concentration in Groundwater (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

metconazole, resulting from use on 

soybeans for acute exposures are 

estimated to be 1.57 parts per billion 

(ppb) for surface water and 0.04 ppb for 

ground water. The EDWCs for chronic 

exposures are estimated to be 0.48 ppb 

for surface water and 0.04 ppb for 

ground water. Use on imported bananas 

will not contribute to residues in water 

in the United States. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Metconazole is not registered for use 

on any sites that would result in 

residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Metconazole is a member of the 

triazole-containing class of pesticides. 

Although conazoles act similarly in 

plants (fungi) by inhibiting ergosterol 

biosynthesis, there is not necessarily a 

relationship between this pesticidal 

activity and their mechanism of toxicity 

in mammals. Structural similarities do 

not constitute a common mechanism of 

toxicity. Evidence is needed to establish 

that the chemicals operate by the same, 

or essentially the same sequence of 

major biochemical events. A variable 

pattern of toxicological responses are 

found for conazoles. Some are 

hepatotoxic and hepatocarcinogenic in 

mice. Some induce thyroid tumors in 

rats. Some induce developmental, 

reproductive, and neurological effects in 

rodents. Furthermore, the conazoles 

have a diverse range of biochemical 

events including altered cholesterol 

levels, stress responses, and altered 

DNA methylation. It is not clearly 

understood whether these biochemical 

events are directly connected to the 

toxicological outcomes. Thus, there is 

currently no evidence to indicate that 

conazoles share common mechanisms of 

toxicity and EPA is not following a 

cumulative risk approach based on a 

common mechanism of toxicity for the 

conazoles. For information regarding 

EPA’s procedures for cumulating effects 

from substances found to have a 

common mechanism of toxicity, see 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative. 

Metconazole is a triazole-derived 

pesticide. This class of compounds can 

form the common metabolite 1,2,4- 

triazole and two triazole conjugates 

(triazole alanine and triazole acetic 

acid). To support existing tolerances 

and to establish new tolerances for 

triazole-derivative pesticides, including 

metconazole, U.S. EPA conducted a 

human health risk assessment for 

exposure to 1,2,4-triazole, triazole 

alanine, and triazole acetic acid 

resulting from the use of all current and 

pending uses of any triazole-derived 

fungicide. The risk assessment is a 

highly conservative, screening-level 

evaluation in terms of hazards 

associated with common metabolites 

(e.g., use of a maximum combination of 

uncertainty factors) and potential 

dietary and non-dietary exposures (i.e., 

high end estimates of both dietary and 

non-dietary exposures). In addition, the 

Agency retained the additional 10X 

FQPA safety factor for the protection of 

infants and children. The assessment 

includes evaluations of risks for various 

subgroups, including those comprised 

of infants and children. The Agency’s 

complete risk assessment is found in the 

propiconazole reregistration docket at 

http://www.regulations.gov, Docket 

Identification (ID) Number EPA–HQ–

OPP–2005–0497. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a Margin of Exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional uncertainty factors 

and/or FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

The database for metconazole is 

adequate for FQPA consideration. The 

two-generation reproduction study was 

performed with cis-only metconazole 

(not cis/trans metconazole). However, 

the database contains a sufficient 

number of subchronic and 

developmental toxicity studies with cis/ 

trans metconazole to adequately assess 

cis/trans metconazole toxicity and to 

bridge the data gap. In addition, 

acceptable development toxicity studies 

are available in both rats and rabbits. 

The effect seen in these studies do not 

indicate that pups are more susceptible: 

pup effects were only seen in the 

presence of maternal toxicity and, in 

general, were of comparable or less 

severity to the effects observed in 

adults. Metconazole did not exhibit 

neurotoxicity in any of the submitted 

data. 

3. Conclusion. There is a complete 

toxicity data base for metconazole and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. There 

is no evidence of susceptibility 

following in utero and/or postnatal 

exposure in the developmental toxicity 

studies in rats or rabbits, and in the 2- 

generation rat reproduction study. There 

are no residual uncertainties concerning 

prenatal and postnatal toxicity and no 

neurotoxicity concerns. The acute and 

chronic dietary (food + drinking water) 

exposure assessments are conservative 

assessments that are based on reliable 

data and will not underestimate 

exposure/risk. There is no potential for 

drinking water exposure from the 

proposed use on imported bananas. 

Additionally, there is no potential for 

residential exposure. Based on these 

data and conclusions, the FQPA Safety 

Factor is reduced to 1X. 

E. Aggregate Risks and Determination of 

Safety 

To assess aggregate risk, drinking 

water estimates were incorporated 

directly into the dietary analysis, rather 

than using back-calculated drinking 

water levels of comparison (DWLOCs). 


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To better evaluate aggregate risk 

associated with exposure through food 

and drinking water, EPA is no longer 

comparing Estimated Drinking Water 

Concentrations (EDWCs) generated by 

water quality models with DWLOC. 

Instead, EPA is now directly 

incorporating the actual water quality 

model output concentrations into the 

risk assessment. This method of 

incorporating water concentration into 

our aggregate assessments relies on 

actual CSFII reported drinking water 

consumptions and more appropriately 

reflects the full distribution of drinking 

water concentrations. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

metconazole will occupy < 1% of the 

aPAD for females 13 years and older, the 

only population subgroup of concern. 

EPA does not expect the aggregate 

exposure to exceed 100% of the aPAD, 

and therefore is below the Agency’s 

level of concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to metconazole from food 

and water will utilize 2% of the cPAD 

for the U.S. population, 5% of the cPAD 

for children 1-2 years old, the most 

highly exposed population subgroup. 

There are no residential uses for 

metconazole that result in chronic 

residential exposure to metconazole. 

EPA does not expect the aggregate 

exposure to exceed 100% of the cPAD, 

and therefore is below the Agency’s 

level of concern. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Metconazole is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Metconazole is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. The Agency has classified 

metconazole as ‘‘Not Likely to be 

Carcinogenic to Humans’’ based on 

convincing evidence that carcinogenic 

effects are not likely below a defined 

dose range and that carcinogenic effects 

were seen in animals only at higher 

doses. A non-genotoxic mode of action 

for mouse liver tumors was established. 

Given that metconazole’s cancer effects 

are a threshold effect and that the 

threshold is well above other chronic 

effects, the chronic RfD is protective 

against any cancer risk. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population and to infants and children 

from aggregate exposure to metconazole 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(gas chromatography/nitrogen 

phosphorus detection (GC/NPD) method 

(American Cyanamid Method M 2722)) 

is available to enforce the tolerance 

expression. The method may be 

requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no Canadian, 

Mexican or Codex MRL or tolerances for 

metconazole. 

C. Response to Comments 

A private citizen responded to PP 

9E5052. Comments were received on 

April 17, 2005 objecting to the use and 

sale of this product, animal testing, 

profiteering and lack of satisfactory 

combined and long-term testing. The 

Agency response is as follows: The 

Agency has a toxicity data base and it 

is considered sufficient to adequately 

assess metconazole, which includes 

several long-term or chronic studies. 

The commenter submitted no scientific 

information or data to support their 

claims. EPA has responded to such 

generalized comments on numerous 

previous occasions, for example, on 

January 7, 2005 (70 FR 1354) (FRL–

7681–9) and on October 29, 2004 (69 FR 

63083) (FRL–7691–4). 

V. Conclusion 

Therefore, a tolerance is established 

for residues of metconazole, 5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol, in or on banana 

at 0.1 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–13, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 


sroberts on PROD1PC70 with RULES
56388 Federal Register / Vol. 71, No. 187 / Wednesday, September 27, 2006 / Rules and Regulations 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive Order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 18, 2006. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Section 180.617 is added to read as 

follows: 

§ 180.617 Metconazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for the residue of the 

fungicide metconazole (5-[(4- 

chlorophenyl)methyl]-2,2-dimethyl-1- 

(1H-1,2,4-triazol-1- 

ylmethyl)cyclopentanol) in or on the 

following commodity: 

Commodity Parts per million 

Banana1 ................ 0.1 

1 No U.S. registration as of August 30, 2006. 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 06–8256 Filed 9–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0058; FRL–8091–5] 

Ethaboxam; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of ethaboxam in 

or on grape at 6.0 parts per million 

(ppm), with no U.S. registration. Landis 

International, Inc., agent for LG Life 

Sciences, Ltd. requested this tolerance 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA). 

DATES: This regulation is effective 

September 27, 2006. Objections and 

requests for hearings must be received 

on or before November 27, 2006, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2005–0058. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. 

S–4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Bryant Crowe, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–0025; e-mail address: 

crowe.bryant@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides a guide 


sroberts on PROD1PC70 with RULES